Technical Project Manager - QE/CAPA Specialist

Reimagine the infrastructure of cancer care within a community that values integrity, inspires growth, and is uniquely positioned to create a more modern, connected oncology ecosystem.
We're looking for a Technical Project Manager with experience in regulatory compliance and software development to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be the next changemaker in cancer care?
What You'll Do
You'be be embedded in the Product Management team, and will work primarily with the Product, Engineering, Project Management and Risk Management (Quality) teams supporting Flatiron's Clinical Research Business Unit (CRBU). You will be responsible for the management of in-process compliance and continuous improvement activities. Such support includes collaborating with key stakeholders and leadership. In addition, you'll also:

• Own and drive forward the Quality Event (QE) and Corrective And Preventive Action (CAPA) processes as a technical project manager. This includes assisting the Product & Engineering teams with drafting of supporting documentation, liaising with the Quality and Project Management teams, and ensuring that all timelines are met.
• Support audit readiness and facilitate vendor qualification processes by providing cross-functional project management and ensuring all documents and evidence are maintained centrally and regularly updated.
• Support audit responsiveness by coordinating evidence and responses, as well as providing internal oversight of associated action plans (e.g., CAPAs).
• Develop, standardize, and continuously improve applicable processes and procedures across the CRBU programs, as well as implement new initiatives with the rapidly growing team.
• Establish/maintain program development milestones and ensure accurate tracking and reporting of metrics and timelines in support of programs to ensure sustained inspection readiness.
• Be the liaison to Quality, Legal, Privacy, Compliance, and Security processes and programs.

Who You Are
You're a technical project manager and QE specialist with at least 3 years of applicable experience. You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. You're a kind, passionate, and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact.

• You have a Bachelor's degree
• You have experience with managing QEs and CAPAs throughout the QE/CAPA lifecycle
• You have experience supporting the software development lifecycle (SDLC) and managing the remediation of bugs and defects
• You have strong technical project management skills and the ability to work within a cross-functional team and manage multiple simultaneous projects
• You have experience working in the technology space, preferably in healthcare

Extra Credit

• You have experience with process improvement methodologies
• You have experience with audit preparation / management
• You have experience working in a GxP environment
• You have familiarity with various Amazon Web Services (AWS) and understand how they are used in the provisioning of software applications
• You have experience with audit preparation / management, preferably including GxP, Security (SOC2 Type II)
• You have direct experience in or supporting software engineering, and have embedded with scrum teams and application development teams

Where you'll work
In this hybrid role, you'll have a defined work location that includes work from home and 3 office days per week in our New York City office. For more information on our approach to hybrid work as well as our work type options, please visit the how we work website.
Life at Flatiron
At Flatiron Health, we offer a full range of benefits to support you and your loved ones so you can focus your working hours on improving cancer care and accelerating cancer research, and your non-working hours on everything else life has to offer:

• Work/life autonomy via flexible work hours and flexible paid time off
• Comprehensive compensation package
• 401(k) contribution to help you reach your retirement planning goals
• Financial health resources including 1:1 financial advice
• Mental well-being tools and services
• Parental benefits and policies including family-building care and generous leave
• Path to parenthood programs supporting fertility, adoption and surrogacy
• Travel support for safe healthcare services

In addition to our robust benefit offerings, visit our Life at Flatiron page to learn how we support continuous learning and celebrate Diversity in the workplace.
Preferred Primary Location: NY hub
The annual pay range reflected above for this position is based on the preferred primary location of the role which is listed in the job description. Salary ranges for other locations vary from the range reflected above. Base pay offered may vary depending on job-related knowledge, skills, and experience. An annual bonus and equity may be provided as part of the compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the position offered.